In the United States, otitis media, next to upper respiratory tract infections, is the most common cause for outpatient visits to pediatricians. Fifteen to twenty per cent of children younger than six years of age contract otitis media. Otitis media is an inflammation of the middle ear characterized by symptoms such as otaigia, hearing loss and fever. One of the primary causes of these symptoms is a build up of fluid (effusion) in the middle ear. Complications include permanent hearing loss, perforation of the tympanic membrane, acquired cholesteatoma, mastoiditis, and adhesive otitis. Children who develop otitis media in the first years of life are at risk for recurrent acute or chronic disease.
One of the primary causes of otmis media is Haemophilus influenzae, which is commonly known as "H. influenzae." It is thought that H. influenze causes otitis media by adhering to nasopharyngeal cells. The adherence of H. influenze to nasopharyngeal cells causes those cells to become infected and to produce secretions. The middle ear becomes infected because mechanical or functional obstruction of the Eustachian tube, which protects the middle ear from nasopharyngeal secretions, results in negative middle ear pressure. This negative pressure causes the nasopharyngeal secretions to enter the middle ear resulting in an infection, such as otitis media, usually with effusion.
Typically, otitis media is treated by means of administering a course of antibiotics consisting of a penicillin derivative. Other supportive therapies, such as analgesics, antipyretics and local heat are also helpful. Often, surgery is required to remove fluid from the middle ear and to relieve the pain experienced by the child.
Currently, no reliable prophylactic treatments are known. It has been demonstrated that human casein inhibits the adhesion of H. influenze to human respiratory tract epithelial cells. See Aniansson, et. al., Microbial Pathogenesis 1990;8:315 -323. Aniansson, et al., found that human casein represents a new mechanism for the protection by breast-milk against respiratory tract infection. Thus, it is thought that human casein may be effective as a prophylactic treatment for otitis media but further study is required.
Polyphosphoinositides have been reported to be present in inner ear and kidney tissue. See U.S. Pat. No. 4,897,384 to Janoff, et al. Phosphatidylinositol diphosphate has been postulated to serve as an in vivo receptor for aminoglycoside antibiotics. See Lodhi, et al., Biochem. Pharmacol. 29:597-601 (1990).
Dipalmitoylphosphatidylinositol-3,4-diphosphate ammonium salt (PI-3,4-PP) is known to be a membrane lipid present in human erthyrocytes. However, no antibacterial activity of polyphosphoinositides has been previously reported.
For these reasons, a need still exists in the art for a composition and method for the prophylaxis and treatment of infections caused by Haemophilus influenzae and its clinical manifestations, such as, for example, otitis media.